Nanomaterials in medical devices

Nanomaterials are found throughout the medical devices industry. Favoured for their enhanced mechanical, biological and chemical properties, they are used in devices including synthetic bone grafts, wound dressings and medical instruments.

As a Notified Body, our team of experts have experience in material science and device design, particularly in orthopaedic and dental devices, active implantable devices and woundcare.

Nanomaterials are found in a range of medical devices. Manufacturers need to consider how the use of nanomaterials impacts the device design, risk, biocompatibility, toxicity, and the other chemical, physical and biological properties of device.

Nanomaterials resources

Access our complimentary resources on nanomaterials:

Co-authored by Professor Peter Dobson of the Queen's College, Oxford, and Dr. Matthew O'Donnell, Orthopaedic and Dental Technical Team Manager at BSI, our new white paper explores the application of nanomaterials in the medical devices industry. It reviews the current uses and the changing regulatory requirements for devices utilizing these materials.

You can also learn from BSI expert, Dr Matthew O'Donnell, about the importance of nanomaterials in medical devices in our recent webinar.

Devices containing nanomaterials

Nanomaterials are incresingly used in medical devices, as their benefits are now being realised. However, increasing use has also led to more regulatory scrutiny.

Nanomaterials are defined by Recommendation 2011/696/EU as unbound or aggregate particles where at least half of the particles have external dimensions of 1-100nm. While there are no explicit requirements in the current MDD, AIMDD or IVDD in relation to nanomaterials, these are present in the new EU Medical Devices Regulation (MDR) and IVD Regulation (IVDR), which include specific classification rules for devices incorporating or consisting of nanomaterial. This risk-based approach allows more scrutiny of nanomaterials, based on current uncertainties over their environmental, biological, and toxicological risk.

It is important that manufacturers identify the use of nanomaterials in their devices to ensure that they meet the requirements of the new Regulations. There are a number of general ISO standards on nanotechnology and toxicology of nanomaterials, and a Technical Report with guidance on the biological evaluation of medical devices containing or generating nanomaterials. However there are no specific standards on nanomaterials in medical devices.

Why choose BSI for certification?

The BSI Medical Devices team has a wealth of experience with all kinds of medical technologies. Our dedicated experts are knowledgeable about specific device technologies and have experience in device design and manufacturer. This allows our team to provide a rigourous, hollistic review of your device, considering all these important factors.